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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K141693
Device Name Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
Applicant
Advanced Sterilization Products
33 Technology Dr.
Irvin,  CA  92618
Applicant Contact SUN CHOI
Correspondent
Advanced Sterilization Products
33 Technology Dr.
Irvin,  CA  92618
Correspondent Contact SUN CHOI
Regulation Number880.6850
Classification Product Code
FRG  
Subsequent Product Code
JOJ  
Date Received06/24/2014
Decision Date 12/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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